Evidence map›Paper›PMID 30683146›Full record

ArticleTrials2019

The Evaluation of Vitiligous lesions Repigmentation after the Administration of Atorvastatin calcium salt and Simvastatin-acid sodium salt in patients with active vitiligo (EVRAAS), a pilot study: study protocol for a randomized controlled trial.

Anna Niezgoda, Andrzej Winnicki, Tomasz Kosmalski, Bogna Kowaliszyn, Jerzy Krysiński, Rafał Czajkowski

Registry-linked trialOpen access · goldAbstract readClinical Trial Protocol
In one paragraph

Article in Trials, 2019. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT03247400 (The Evaluation of Vitiligous Lesions Repigmentation After the Administration of Atorvastatin Calcium Salt and Simvastatin-acid Sodium Salt in Patients With Active Vitiligo), which is not on this map. Cited by 5 papers.

0numbers the graph read from it
0cells of the map it votes in
5citing papers in PubMed
1.1field-weighted citation impact, top 26% of its field
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

NCT03247400 phase1 / phase2completednot on this map

The Evaluation of Vitiligous Lesions Repigmentation After the Administration of Atorvastatin Calcium Salt and Simvastatin-acid Sodium Salt in Patients With Active Vitiligo (EVRAAS)

TypeinterventionalSponsorNicolaus Copernicus UniversityRan2016 to 2019Enrolled24ConditionsNon-segmental VitiligoArms1% simvastatin-acid sodium salt ointment, 1% atorvastatin calcium salt ointment
3 · Its place in the literature

Who cites it

5 citing papers in PubMed, 19 citations in OpenAlex.

  1. Trial
  2. Review
  3. Emerging Therapeutic Innovations for Vitiligo Treatment.Current issues in molecular biology · 2025
    Review
  4. Research Progress on Targeted Antioxidant Therapy and Vitiligo.Oxidative medicine and cellular longevity · 2022
    Review
  5. Review
4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

6 authors at 1 institution in 1 country.

Anna NiezgodaThe Department of Dermatology, Sexually Transmitted Diseased and Immunodermatology, Nicolaus Copernicus University, Collegium Medicum in Bydgoszcz, Bydgoszcz, Poland. anna.niezg@gmail.com.ORCID http://orcid.org/0000-0002-8189-7520
Andrzej WinnickiThe Department of Pharmaceutical Technology, Nicolaus Copernicus University, Collegium Medicum in Bydgoszcz, Bydgoszcz, Poland.
Tomasz KosmalskiThe Department of Organic Chemistry, Nicolaus Copernicus University, Collegium Medicum in Bydgoszcz, Bydgoszcz, Poland.
Bogna KowaliszynGenetics and Fundamentals of Animal Breeding, Technical and Agricultural Academy in Bydgoszcz, Bydgoszcz, Poland.
Jerzy KrysińskiThe Department of Pharmaceutical Technology, Nicolaus Copernicus University, Collegium Medicum in Bydgoszcz, Bydgoszcz, Poland.
Rafał CzajkowskiThe Department of Dermatology, Sexually Transmitted Diseased and Immunodermatology, Nicolaus Copernicus University, Collegium Medicum in Bydgoszcz, Bydgoszcz, Poland.
Nicolaus Copernicus University · PL

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundVitiligo is a chronic skin disorder presenting with depigmentation, the pathogenesis of which is complex but the autoimmune theory is now preferred. Multiple immunologic processes, including stimulation of the T-helper (Th)1 response, formation of autoreactive melanocyte-specific CD8 METHODS/

designA study has been designed as a single-center, randomized, double-blind, placebo-controlled pilot study with the enrollment of at least 24 active NSV patients presenting with vitiligous lesions on both upper and lower limbs. The clinical effects of ointments containing 1% simvastatin-acid sodium salt or 1% atorvastatin calcium salt applied on a preselected limb will be assessed in comparison with vehicle ointment applied on the opposite limb. All study participants will undergo clinical evaluation using body surface area (BSA) and Vitiligo Area Scoring Index (VASI) scales at baseline and at weeks 4, 8, and 12 time points. A precise assessment of skin lesions will be performed using photographic documentation obtained during each study visit and processed with NIS-Elements software. DISCUSSION: Currently available vitiligo topical therapeutic approaches including calcineurin inhibitors and corticosteroids remain poorly effective and are associated with either relatively high cost or potentially dangerous adverse effects. The clinical application of orally administrated statins, widely used as systemic cholesterol-lowering agents, in vitiligous patients has only been tested in two clinical trials; however, data on their potential usefulness is scarce. Moreover, due to a high risk of clinically significant toxicity, topical administration was recommended by researchers. This study is the first to evaluate safety and efficacy of the topical use of statins in patients presenting with NSV.

trial registrationClinicaltrials.gov, NCT03247400 . Registered on 05 August 2017.

Indexed as

Administration, TopicalAdultAgedAged, 80 and overAtorvastatinDouble-Blind MethodFemaleHumansMaleMiddle AgedOintmentsPilot ProjectsRandomized Controlled Trials as TopicSimvastatinSkin PigmentationVitiligoAtorvastatinOintmentsSimvastatinsimvastatin acidAtorvastatinRCTRepigmentationSimvastatinStatinsTopicalTreatmentVitiligo

Identifiers

PMID30683146
PMCPMC6346543
OpenAlexW2923800530

What OpenQuestion holds

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LicenceCC BY
Read underepoch 390

Registered trials

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.